LT Vaccine Patch Self-Administration Study

NCT ID: NCT00565461

Last Updated: 2020-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2008-08-31

Brief Summary

To evaluate the immune responses achieved following self-administered heat-labile enterotoxin of E. coli (LT) vaccination by transcutaneous immunization compared to the immune responses achieved by clinician-administered vaccination.

Conditions

Prevention of Travelers' Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 1

40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician

Group Type: EXPERIMENTAL

heat-labile enterotoxin of E. coli (LT)

Intervention Type: BIOLOGICAL

37.5ug patch applied on either the deltoid or the thigh

Group 2

40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician.

Group Type: EXPERIMENTAL

heat-labile enterotoxin of E. coli (LT)

Intervention Type: BIOLOGICAL

37.5ug patch applied on either the deltoid or the thigh

Group 3

40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.

Group Type: EXPERIMENTAL

heat-labile enterotoxin of E. coli (LT)

Intervention Type: BIOLOGICAL

37.5ug patch applied on either the deltoid or the thigh

Group 4

40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.

Group Type: EXPERIMENTAL

heat-labile enterotoxin of E. coli (LT)

Intervention Type: BIOLOGICAL

37.5ug patch applied on either the deltoid or the thigh

Interventions

heat-labile enterotoxin of E. coli (LT)

37.5ug patch applied on either the deltoid or the thigh

Intervention Type: BIOLOGICAL

Other Intervention Names

TD Vaccine System

Eligibility Criteria

Inclusion Criteria

• Healthy adult males or females 18-64 years of age with signed Informed Consent.
• Women who are not post-menopausal or surgically sterile must have a negative serum or urine pregnancy test at screening and within 24 hours of each vaccination with understanding (through Informed Consent process) to not become pregnant over the duration of the study, and must agree to employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: abstinence, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom or diaphragm, with spermicide), and IUD.

Exclusion Criteria

Subjects meeting any of the following criteria are not eligible for participation in the study:

• Laboratory abnormalities [as determined by the Toxicity Grading Scale (grade 1-4)] at laboratory screening
• Abnormalities at physical examination [as determined by the Toxicity Grading Scale (grade 1-4)]
• Known allergies to any component of the vaccine
• Known allergies to adhesives
• Participated in research involving investigational product within 30 days before planned date of first vaccination
• Donated blood or blood products such as plasma within the past 30 days
• Ever received investigational enterotoxigenic E. coli, LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd
• Ever received cholera toxin or vaccine (e.g. Orochol™, Dukoral™)
• History of traveler's diarrhea in the previous two years
• History of abdominal surgery (excluding C-Section, hysterectomy, cosmetic surgery, liposuction, appendectomy, cholecystectomy, ventral hernia repair, and other surgeries not pertaining to gastrointestinal problems) or history of, or recent acute gastrointestinal (GI) illness
• Positive serology for HIV-1, HIV-2, HBsAg, or HCV
• Medical history of acute or chronic skin disease at vaccination area(s)
• Active skin allergy
• Signs of acute skin infection, sunburn or skin abnormalities at the vaccination area(s) including fungal infections, severe acne, or active contact dermatitis, or a history of keloid formation
• Excessively hirsute at the vaccination area(s) that would interfere with patch adhesion in the opinion of the Investigator
• Visible tattoos or marks (tattoos/scars) at the vaccination area(s) that would prevent appropriate dermatologic monitoring of the vaccination site(s)
• Fever greater than or equal to 38.0°C (100.4°F) at the time of planned vaccination
• Women who are pregnant or breastfeeding
• Acute illness at screening or at baseline; or
• Employee of the investigational site.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Intercell USA, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judith Forte, MD

Role: PRINCIPAL_INVESTIGATOR

Arkansas Medical Research Testing

Locations

Arkansas Medical Research Testing

Little Rock, Arkansas, United States

Miami Research Associates

South Miami, Florida, United States

Jean Brown Research

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

ELT203

Identifier Type: -

Identifier Source: org_study_id